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. 2019 Mar 25;2019(3):CD012387. doi: 10.1002/14651858.CD012387.pub2

Given 2004.

Methods RCT – with an intervention group (IG) and control group (CG)
Participants Patients diagnosed with a solid tumour and within 56 days of undergoing a first cycle of chemotherapy
Country: USA
Age: unclear
Sex: Almost 80% of the total sample female
Inclusion criteria:
  1. diagnosed with a solid tumour

  2. within 56 days of undergoing a first cycle of chemotherapy

  3. having a family member who agreed to be the informal caregiver of record

  4. caregiver and patient need to be able to speak and read English

  5. cognitively intact


Exclusion criteria
  1. undergone a previous course of chemotherapy or receiving radiation


N randomised: n = 237; IG: n = 118; CG: n = 119
N in analysis: baseline: n = 237, IG: n = 118, CG: n = 199; 10 weeks: n = 191, IG: n = 97, CG: n = 94; 20 weeks: n = 167, IG: n = 80, CG: n = 87
Interventions Content of screen:HRQoL: Assessment of severity of problems and extent to which each of these problems impacted QoL ‐ dimensions. Problems assessed: alopecia, anxiety, constipation, depression, diarrhoea, nausea, dyspnoea, fatigue, fever, anorexia, insomnia, mucositis, pain, skin problems, lack of concentration, and physical and work role functioning; QoL dimensions assessed: emotions, relationships with others, sleep, appetite, daily activity, and concentration
Interventionist: A nurse to conduct the screening/assessment and broader intervention
Intervention procedure:SI with co‐intervention to use screening results: A 10‐contact, 20‐week intervention with symptom assessment. The computer documentation system provided up to 4 intervention strategies for each detected problem selected from the categories: information, counselling and support, co‐ordination of care, and prescribing therapeutic activities. Nurse discussed and entered participants’ choice into computer‐guided protocol. At all subsequent contacts, participants rated the severity and impact on symptoms for each specific intervention. Evaluation of each problem classified as: resolved, improving, no change, or deteriorating. Each of the in‐person sessions took approximately 1 hour
Conditions for implementation
  1. development of a computer system with predefined roster of interventions related to detected problems

  2. training of intervention nurses in assessing patients and use of computer system


Comparative condition: Usual care group
Length of follow‐up: 20 weeks
Outcomes Primary outcomes: Depression (CES‐D)
Secondary outcomes: /
Outcome time points: baseline; 10 and 20 weeks
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation not specified
Allocation concealment (selection bias) Unclear risk Unclear which method was used to conceal the allocation to conditions
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants, partners, and nurses not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information on blinding of telephone (outcome) interviewers
Incomplete outcome data (attrition bias) 
 All outcomes High risk Dropout from baseline to 20 weeks' postbaseline: 32% in control group, 27% in intervention group
Selective reporting (reporting bias) High risk Data on participant characteristics are very limited, no clear presentation on the concrete depression data (CES‐D scores) or severity of problems data, only a lot of visuals and text on the assessed interactions. There is also no referral to a supplementary file for the concrete data
Other bias Unclear risk Not clear whether the differently composed models are post hoc analyses or were planned in advance